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NCT01825005 Clinical Trial

Predicting Outcome in Cervix Carcinoma: a Prospective Study

Cervical Cancer Clinical Trial

— POCER  

Official title:
Predicting Outcome in Cervix Carcinoma: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01825005
Other study ID # 12-4-008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date August 2018

Study information
Verified date May 2019
Source Maastricht Radiation Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.

Recruitment information / eligibility
Status Completed
Enrollment 423
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- histological or cytological proven cervical cancer

- informed consent according to national rules

Exclusion Criteria:

- no histological or cytological proven cervical cancer

- no informed consent according to national rules

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Maastricht University Hospital Maastricht
South Africa Bloemfontein medicross Bloemfontein Free State

Sponsors (1)
Lead Sponsor Collaborator
Maastricht Radiation Oncology

Countries where clinical trial is conducted

Netherlands,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary five-year overall survival rate assessment of the overall survival 5 years after treatment 5 years after treatment
Secondary three-year distant disease free survival assessment of distant disease free survival, 3 years after treatment 3 years
Secondary three-year local disease free survival assessment of local disease free survival, 3 year after treatment 3 years
Secondary five-year distant disease free survival assessment of distant disease free survival,5 years after treatment 5 years
Secondary five-year local disease free survival assessment of local disease free survival, 5 years after treatment 5 years
Secondary number of participants with early adverse events as a measure of safety and tolerability 2 months
Secondary number of participants with late adverse events as a measure of safety and tolerability 5 years
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